MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number SP4153108DB

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer is confirmed; however, the exact cause is unknown.One 3.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The dilator was returned loose within the introducer sheath and was observed to be bent approximately 0.2 cm and 1.9 cm distal to the locking collar.A bend was also observed in the introducer sheath just distal to the t-handle.The bend in the introducer sheath appears to align with the bend 1.9 cm distal to the locking collar in the dilator; however, the dilator in this position was found to protrude slightly from the introducer sheath and not locked onto the t-handle of the introducer sheath.A microscopic observation revealed the distal tip of the introducer sheath was damaged and plastically deformed in multiple locations around its circumference, and the edges of the sheath tip were observed to flare outward.No damage was observed on the distal tip of the dilator.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.As a note, the product ifu states: ¿do not withdraw dilator from microintroducer sheath until sheath is within vessel to minimize the risk of damage to sheath tip.¿ a lot history review (lhr) of reeq0652 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported a defect was found with an introducer, not allowing it to thread in easily.Additional information received via medwatch "vat nurse placing a midline, unable to thread in introducer, even after nicking the patient, introducer removed and that is when the defect was noticed, a new midline kit opened to retrieve second introducer, no issues after using new introducer.It was reported this occurred twice.This report addresses the first event.

• Brand Name: DOT 3FR SL PROV ML
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11060901
• MDR Text Key: 223796169
• Report Number: 3006260740-2020-21036
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: SP4153108DB
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REEQ0652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other